Evaluating Neurologic Changes After a New Heart Surgery Technique
A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery
Tongji Hospital · NCT06078410
This study is testing a new heart surgery technique to see how it affects brain health and thinking skills in patients with a specific heart condition compared to traditional surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06078410 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess neurologic changes in patients who undergo a novel surgical procedure called transapical beating-heart septal myectomy for hypertrophic obstructive cardiomyopathy. Participants will receive detailed neurologic and cognitive assessments before the procedure, immediately after, and again at 30 days post-operation. The study will compare the neurologic outcomes and brain lesions of these patients with those undergoing traditional cardiac surgeries. The researchers will utilize cognitive evaluation forms and diffusion-weighted magnetic resonance imaging (DW-MRI) to measure any potential neurologic impairments resulting from the surgery.
Who should consider this trial
Good fit: Ideal candidates include patients with hypertrophic obstructive cardiomyopathy or other conditions requiring left heart operations who are eligible for the transapical beating-heart septal myectomy.
Not a fit: Patients with severe recent brain infarctions, cognitive impairments, or those unable to undergo MRI examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of a new heart surgery technique and its impact on neurologic health.
How similar studies have performed: While the specific approach of transapical beating-heart septal myectomy is novel, previous studies have shown that cardiac surgeries can lead to neurologic complications, indicating a need for this type of evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: meets indications for transapical beating-heart septal myectomy procedure or these cardiac surgery involving left heart operation, such as hypertrophic obstructive cardiomyopathy, mitral valve prolapse, and ventricular septal defect; willing to comply with protocol-specified follow-up evaluations. Exclusion Criteria: severe brain infarction, such stroke and cerebral hemorrhage recently; the implantation of metal materials, including Pacemaker; not able to undergo MRI examination; peptic ulcer or recent gastrointestinal bleeding (\<6 months); the history of myocardial infarction; cognitive impairment in the past; not able to finish nervous system evaluation scale.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Xiang Wei, M.D.
- Email: xiangwei@tjh.tjmu.edu.cn
- Phone: +8613995525956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertrophic Obstructive Cardiomyopathy \, Neurologic Evaluation, Magnetic Resonance Imaging \, Transapical Beating-Heart Septal Myectomy, Cardiac Surgery Involving Left Heart Operation